A Study of MabThera (Rituximab) in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia And Favorable Somatic Status

This study is currently recruiting participants.

Verified May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01271010

First received: January 4, 2011

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 4, 2011

Last Updated Date

May 7, 2013

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

October 2018 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Therapy response rate of MabThera in combination with fludarabine and cyclophosphamide [ Time Frame: 60 months ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 60 months ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
Event-free survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: 60 months ] [ Designated as safety issue: No ]
Reasons for different efficacy and safety of MabThera in patients [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01271010 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of MabThera (Rituximab) in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia And Favorable Somatic Status

Official Title ^ICMJE

Prospective Study of Efficacy and Safety of RFC (Rituximab, Fludarabine, Cyclophosphamide) Regimen as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Favorable Somatic Status

Brief Summary

This multi-center, single-arm study will evaluate the efficacy and safety of MabThera (rituximab) in combination with fludarabine and cyclophosphamide in patients with B-cell chronic lymphocytic leukemia and favorable somatic status. Patients will receive MabThera 375 mg/m2 intravenously on Day 1 of Cycle 1, and then 500 mg/m2 on Day 1 of the following 5 cycles, fludarabine 25 mg/m2 intravenously or 40 mg/m2 orally on Days 1-3 of every cycle and cyclophosphamide 250 mg/m2 intravenously or orally on Days 1-3 of every cycle. The anticipated time on study drug is 6 months.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Lymphocytic Leukemia, Chronic

Intervention ^ICMJE

Drug: rituximab [MabThera]
375 mg/m2 intravenously on Day 1 of Cycle 1, then 500 mg/m2 intravenously on Day 1 of 5 cycles of 28 days lengths
Drug: fludarabine
25 mg/m2 intravenously or 40 mg/m2 orally on Days 1-3 of cycles 1-6 of 28 days lengths each
Drug: cyclophosphamide
250 mg/m2 intravenously or orally on Days 1-3 of cycles 1-6 of 28 days length each

Study Arm (s)

Experimental: 1

Interventions:

Drug: rituximab [MabThera]
Drug: fludarabine
Drug: cyclophosphamide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

October 2018

Estimated Primary Completion Date

October 2018 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients, age 18-70 years
Diagnosis of previously untreated B-cell chronic lymphocytic leukemia
For patients, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity score </=6
Binet stage B, C or A with progression
Life expectancy >/=12 months
Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

Patients with small-cell lymphoma
Patients with auto-immune hemolytic anemia
Concomitant malignant disease during enrollment, except basal cell carcinoma of the skin
Chemotherapy for concomitant disease give within 12 months prior to study enrollment
Patients with Richter's Syndrome

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: ML25136 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

Russian Federation

Administrative Information

NCT Number ^ICMJE

NCT01271010

Other Study ID Numbers ^ICMJE

ML25136

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top